U.S. patent application number 14/056805 was filed with the patent office on 2014-04-17 for adjustable pessary device and method.
The applicant listed for this patent is AMS Research Coproation. Invention is credited to Benjamin Y. Arcand, Janet L. DeMarchi, Justin H. Huelman.
Application Number | 20140107402 14/056805 |
Document ID | / |
Family ID | 50475940 |
Filed Date | 2014-04-17 |
United States Patent
Application |
20140107402 |
Kind Code |
A1 |
Arcand; Benjamin Y. ; et
al. |
April 17, 2014 |
Adjustable Pessary Device and Method
Abstract
Various embodiments of an adjustable pessary device are
provided. The device can include an elastic ribbon or band, such as
Nitinol, encapsulated in a soft or flexible structure, such as a
rubber shell. In addition to providing a conforming, comfortable
shape, the rubber layer can have additional structures to interface
and fit with the anatomical structures within the vagina.
Inventors: |
Arcand; Benjamin Y.;
(Minneapolis, MN) ; Huelman; Justin H.; (Lino
Lakes, MN) ; DeMarchi; Janet L.; (Minnetonka,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AMS Research Coproation |
Minnetonka |
MN |
US |
|
|
Family ID: |
50475940 |
Appl. No.: |
14/056805 |
Filed: |
October 17, 2013 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61714936 |
Oct 17, 2012 |
|
|
|
Current U.S.
Class: |
600/29 |
Current CPC
Class: |
A61F 6/08 20130101; A61F
2/005 20130101 |
Class at
Publication: |
600/29 |
International
Class: |
A61F 2/00 20060101
A61F002/00; A61F 6/08 20060101 A61F006/08 |
Claims
1. A conformable medical device for treating incontinence,
comprising: a flexible outer housing; and an inner band including
at least two elastic undulating ribbon members disposed within the
flexible outer housing such that the device is insertable within a
patient's vagina to treat incontinence.
2. The device of claim 1, wherein the outer housing includes a
lumen to receive the inner band.
3. The device of claim 1, wherein the outer housing is constructed
of a rubber material.
4. The device of claim 1, wherein at least one of the at least two
elastic undulating ribbon members is twisted along its axis.
5. The device of claim 1, wherein at least one of the at least two
elastic undulating ribbon members are twisted at least one full
turn along their length.
6. The device of claim 5, wherein the two elastic undulating ribbon
members each twist in opposing directions.
7. The device of claim 1, wherein the inner band is constructed of
a polymer material.
8. The device of claim 1, wherein the inner band is constructed of
a Nitinol material.
9. The device of claim 1, wherein the inner band is constructed of
a stainless steel material.
10. The device of claim 1, wherein the inner band is generally
S-shaped.
11. An adjustable pessary device to treat incontinence, comprising:
a flexible outer housing including a first undulating member and a
second undulating member; and an inner band including first and
second undulating ribbon members, the first undulating ribbon
member disposed within the first undulating member of the outer
housing and the second undulating ribbon member disposed within the
second undulating member of the outer housing.
12. The device of claim 11, wherein the outer housing is
constructed of a rubber material.
13. The device of claim 11, wherein the first and second undulating
ribbon members are constructed of a shape-memory material.
14. The device of claim 11, wherein the first and second undulating
ribbon members are twisted at least one full turn along their
respective lengths.
15. The device of claim 14, wherein the first and second undulating
ribbon members each twist in opposing directions.
16. The device of claim 11, wherein the inner band is constructed
of a polymer material.
17. The device of claim 11, wherein the inner band is constructed
of a Nitinol material.
18. The device of claim 11, wherein the inner band is constructed
of a stainless steel material.
19. The device of claim 11, wherein at least one of the first and
second undulating ribbon members is generally S-shaped.
20. The device of claim 11, wherein the outer housing is at least
in part generally S-shaped.
Description
PRIORITY
[0001] This Application claims priority to and the benefit of U.S.
Provisional Patent Application No. 61/714,936, filed Oct. 17, 2012,
which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to treatment methods
and apparatus and, more specifically, to an adjustable pessary
device for use in treating incontinence or other pelvic
disorders.
BACKGROUND OF THE INVENTION
[0003] Pelvic health for men and women is a medical area of
increasing importance, at least in part due to an aging population.
Examples of common pelvic ailments include incontinence (e.g.,
fecal and urinary), pelvic tissue prolapse (e.g., female vaginal
prolapse), and conditions of the pelvic floor.
[0004] Urinary incontinence can further be classified as including
different types, such as stress urinary incontinence (SUI), urge
urinary incontinence, mixed urinary incontinence, among others.
Other pelvic floor disorders include cystocele, rectocele,
enterocele, and prolapse such as anal, uterine and vaginal vault
prolapse. A cystocele is a hernia of the bladder, usually into the
vagina and introitus. Pelvic disorders such as these can result
from weakness or damage to normal pelvic support systems.
[0005] Urinary incontinence can be characterized by the loss or
diminution in the ability to maintain the urethral sphincter closed
as the bladder fills with urine. Male or female stress urinary
incontinence (SUI) generally occurs when the patient is physically
stressed.
[0006] In its severest forms, vaginal vault prolapse can result in
the distension of the vaginal apex outside of the vagina. An
enterocele is a vaginal hernia in which the peritoneal sac
containing a portion of the small bowel extends into the
rectovaginal space. Vaginal vault prolapse and enterocele represent
challenging forms of pelvic disorders for surgeons. These
procedures often involve lengthy surgical procedure times.
[0007] Urinary incontinence can be characterized by the loss or
diminution in the ability to maintain the urethral sphincter closed
as the bladder fills with urine. Male or female stress urinary
incontinence (SUI) occurs when the patient is physically
stressed.
[0008] In certain cases, a pessary device is used to help support
the uterus, vagina, bladder or rectum. Vaginal pessary devices can
push the bladder neck up against the pelvic bone, holding it in
place to mimic the natural sphincter mechanism. However,
conventional pessary devices can be ill-suited for a patient's
unique anatomical shapes and sizes. Further, conventional pessary
devices are not readily adjustable without replacing the device or
seeking a physician consultation.
[0009] There is a desire to obtain a minimally invasive yet highly
effective and adjustable pessary device.
SUMMARY OF THE INVENTION
[0010] The present invention describes an adjustable pessary for
treating pelvic conditions such as incontinence (various forms such
as fecal incontinence, stress urinary incontinence, urge
incontinence, mixed incontinence, etc.), vaginal prolapse
(including various forms such as enterocele, cystocele, rectocele,
apical or vault prolapse, uterine descent, etc.), and other
conditions caused by muscle and ligament weakness.
[0011] The adjustable and flexible nature of the device reduces the
issues of device sizing, or requiring multiple device sizes. This,
in turn, opens up the potential for an individual patient to
purchase and use the device in privacy without the need to consult
with a physician.
[0012] Embodiments of the pessary device provide a
multi-directional shape-changing construct. While in the open or
deployed configuration, the device has a generally open oval-like
shape and a generally S-shaped configuration when viewed from the
side, e.g., 90 degrees around the long axis of the oval viewpoint.
When the sides of the oval are squeezed together, the S-shape
simultaneously reduces to a generally linear configuration. This
greatly simplifies insertion, adjustment or placement while
inserted, and removal of the device. Further, the shape memory
nature of the device helps to conform to the appropriate location
in the vagina. The distal portion of the S-shape naturally points
anteriorally and can sit in the space adjacent to the cervix called
the anterior fornix. Continence is achieved by one portion of the
device--e.g., the proximal curve of the S-shape, protruding into
the bladder neck and pubic symphysis. Additional support can be
provided by the proximal end of the S-shape protruding in the
direction of the perineal body.
[0013] The pessary device can include an undulating elastic ribbon
provided therein. The elastic ribbon can be composed of various
materials, including stainless steel, Nitinol, polymer, and the
like. The device can be composed of two ribbons bonded face-to-face
at either end. Between the ends, the ribbon can be twisted about
its axis at least one turn, with the ribbons twisted in opposite
directions. This combination provides a simple and unique method
for providing the shape change characteristic of the device.
Additionally, the ribbon wire or band can be set into a variety of
shapes to alter the overall shape of the device.
[0014] The underlying elastic ribbon or band is generally
encapsulated in a soft or flexible structure, such as a rubber
shell structure. In addition to providing a conforming, comfortable
construct, the rubber layer can have additional structures to
interface and fit with the anatomic structures with the vagina. For
instance, ends of the device might have wedge or saddle-shaped
rubber ends to fit the fornix or perineal body.
[0015] As a self-administered device, the device can have the
advantage of allowing an individual to evaluate and treat their SUI
without the embarrassment of a physician consultation. This can
open up SUI therapy to a large group of women that currently do not
seek treatment. In addition, the device can be packaged with
educational materials to inform the purchaser of permanent
solutions such as SUI slings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIGS. 1A-1D are views an adjustable shape-memory pessary
device in various stages of manipulation and insertion, in
accordance with embodiments of the present invention.
[0017] FIG. 2 is a perspective view of an adjustable shape-memory
pessary device, in accordance with embodiments of the present
invention.
[0018] FIG. 3 is a perspective view of an inner undulating band of
an adjustable pessary device, in accordance with embodiments of the
present invention.
[0019] FIG. 4 is a perspective view of an adjustable shape-memory
pessary device having end saddle-like portions, in accordance with
embodiments of the present invention.
[0020] FIG. 5 is a perspective view of an inner undulating band of
an adjustable pessary device having hinges, in accordance with
embodiments of the present invention.
[0021] FIG. 6 is a schematic view of anatomical structure
illustrating placement of an adjustable pessary device, in
accordance with embodiments of the present invention.
[0022] While the invention is amenable to various modifications and
alternative forms, specifics thereof have been shown by way of
example in the drawings and will be described in detail. It should
be understood, however, that the intention is not to limit the
invention to the particular example embodiments described. On the
contrary, the invention is to cover all modifications, equivalents,
and alternatives falling within the scope of the invention as
defined by the appended claims.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0023] Referring generally to FIGS. 1-6, various embodiments of a
self-adjusting, conformable pessary device 10 are disclosed. In
general, the pessary device 10 can include a generally soft,
flexible outer housing 11, and an elastic wire, ribbon or band 12
encapsulated or otherwise provided within the housing 11--e.g.,
within a housing lumen. The outer housing 11 can include first and
second undulating housing members 11a, 11b (unitary or separate).
The elastic ribbon 12 can be composed of various materials
including stainless steel, Nitinol, polymer, and the like. In
various embodiments, the ribbon 12 is constructed of a shape-memory
material, and can take on an undulating shape. The device 10 can be
composed of two (e.g., first and second) undulating ribbons or
ribbon portions 12a, 12b, bonded face-to-face at either end, or two
or more ribbons 12 attached or provided adjacent (e.g., but not
necessarily bonded) to one another. In other embodiments, the
ribbon portions 12a, 12b are constructed of a single member and
formed or otherwise provided in the desired shape.
[0024] The outer housing 11 can be a flexible structure, such as a
rubber structure (e.g., latex). In addition to providing a
conforming, comfortable shape, the rubber layer 11 can have
additional structures to interface and fit with the anatomical
structures within the vagina. For instance, one or more ends 20 of
the device 10 might have wedge or saddle-shaped rubber ends to fit
the fornix or perineal body (FIG. 4).
[0025] Between the ends, the ribbon 12 can be twisted about its
axis at least one turn, with each ribbon portion 12a, 12b
(face-to-face ribbons) twisted and oriented in opposing directions
(FIG. 3). This configuration provides a simple and unique device
and method for providing shape changing characteristics to
facilitate adjustability. Further, the ribbon wire or band 12 can
be set or otherwise formed into a variety of shapes and sizes to
alter the overall shape of the device to address and treat various
continence goals and patient anatomical structures. In addition,
the shape memory and flexible nature of the device 10 permits easy
readjustment during insertion to better ensure proper placement and
orientation.
[0026] Embodiments of the pessary device 10 provide a
multi-directional shape-changing construct. While in the open or
deployed configuration, the device 10 has a generally open
oval-like, or lily-like, shape (FIGS. 1A-1C, 2). The device has a
generally S-shaped configuration when viewed from the side, e.g.,
90 degrees around the long axis of the oval viewpoint (FIG. 1A).
When the sides of the oval are squeezed together (FIG. 1D) during
insertion, the S-shape reduces or otherwise deforms to a generally
linear configuration, which provides the insertion and removal
configuration for the device 10. Upon reaching the desired location
as described herein, the shape memory nature of the device 10
causes it to generally rebound to its original shape and provide
the desired support to treat incontinence.
[0027] The shape change or memory nature of the device 10 helps to
conform to the appropriate target location in the vagina. A distal
portion 15 of the S-shape naturally points anteriorally and sits in
the space adjacent to the cervix called the anterior fornix.
Continence is achieved by one portion of the device 10, e.g., such
as a proximal curve 17 of the S-shape, protruding into the bladder
neck and pubic symphisis (FIG. 6). Additional support is provided
by a proximal end 16 of the S-shape protruding in the direction of
the perineal body.
[0028] Other embodiments can include portions 12a, 12b connected by
hinges 22, with one hinge 22 provided at each curve or like change
or transition on the S-shape portion 12a, 12b, as shown in FIG. 5.
With such embodiments, a total of four hinges can be included.
Other embodiments can include more or less than four hinges to
facilitate adjustability, manipulation, deployment and seating of
the device 10 within the patient. The hinges 22 can take on various
constructs. For instance, certain embodiments can include living
hinges, pin hinges, crimps or bends in the portions 12a, 12b, ball
hinges, and the like.
[0029] Certain embodiments of the device 10 can be used to evaluate
the required sling tension necessary to adequately control the
patient's stress urinary incontinence. This can be accomplished
with a pessary device 10 that has a calibrated elasticity to
provide a known pressure on the bladder neck, or a gauge that can
be visualized (e.g., markings or indicia) in the proximal portion
of the device. One or more of these devices 10 can be inserted
until it is determined which device 10 provides the desired support
on the bladder neck. Based on the known elasticity or visual
information provided with the device 10, a sling or like implant
device can be chosen to address the corresponding support needs
indicated with the device 10 to promote continence.
[0030] Various other embodiments of the pessary device 10 can be
used to elute a therapeutic agent or substance to aid in SUI
treatment or prepare the tissues for optimal sling placement. For
instance, an estrogen therapy release can be included, such as a
coating or material included with the device or on a device
surface, to increase the tissue thickness of the vaginal wall to
reduce the likelihood of mesh erosion. In another example, an
anti-muscarinic compound can elute from the device 10 (e.g.,
coating or added material to the device) to control an overactive
bladder in mixed incontinence treatment.
[0031] Various methods and tools for introducing or deploying the
devices or systems of the present invention can be used with the
present invention as well. Further, the device and its components
or structures can be constructed of known and compatible materials
know to those skilled in the art, including metals, polymers, and
the like.
[0032] All patents, patent applications, and publications cited
herein are hereby incorporated by reference in their entirety as if
individually incorporated, and include those references
incorporated within the identified patents, patent applications and
publications.
[0033] Obviously, numerous modifications and variations of the
present invention are possible in light of the teachings herein. It
is therefore to be understood that within the scope of the appended
claims, the invention may be practiced other than as specifically
described herein.
* * * * *